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View ICR - OIRA Conclusion

OMB Control No: 0910-0753	ICR Reference No: 201606-0910-003
Status: Historical Active	Previous ICR Reference No: 201512-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaign
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 09/13/2016
	Date Received in OIRA: 07/05/2016
Terms of Clearance: Previous terms continue: Observations and outcomes collected from the respondents participating in the campaign evaluation collections will not be generalized to the broader populations of smokers and/or nonsmokers not participating in the collections affiliated with this OMB control number. Data collected will only be used to directly inform the tobacco prevention campaign objectives and goals.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2019	36 Months From Approved	10/31/2016
Responses	122,717	0	70,618
Time Burden (Hours)	25,208	0	12,612
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	122,717	70,618	52,099
Annual Time Burden (Hours)	25,208	12,612	12,596
Annual Cost Burden (Dollars)	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: FDA requests approval to: 1) conduct a fourth follow-up survey with youth who are part of the first longitudinal cohort, and who participated in the baseline through third follow-up surveys; 2) develop and survey a second longitudinal cohort which will consist of an entirely new sample of youth, ages 11-16 at baseline; 3) extend the media tracking component of the evaluation, and; 4) extend the time period of the rural male smokeless component of the outcome evaluation.

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